(TheRedAlertNews.com) – HAPPENING NOW: A U.S. District Judge in Texas, Matthew Kacsmaryk, has temporarily halted the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone.
In a 67-page opinion, Kacsmaryk criticized the FDA for yielding on safety concerns and employing unsound reasoning and studies that did not justify its conclusions.
The immediate implications of the ruling, which reverses the FDA’s approval of mifepristone in 2000, are uncertain. The injunction does not completely revoke or suspend the FDA’s approval of the abortion drug in response to pro-life groups’ objections.
Kacsmaryk, appointed by President Trump, stayed his opinion for seven days, allowing the Biden administration time to appeal.
Following the opinion’s release, a Washington State federal judge issued a conflicting ruling, which could ultimately escalate the dispute to the Supreme Court.
Attorney General Merrick Garland “strongly disagreed” with the ruling, asserting that the Justice Department would appeal the decision and seek a stay pending appeal. He emphasized that the FDA’s expert judgment established mifepristone’s safety and efficacy over two decades ago, and the Department will continue to defend the FDA’s decision.
The lawsuit, filed by Alliance Defending Freedom on behalf of the Alliance for Hippocratic Medicine and four pro-life doctors, claims the FDA lacked the authority to approve the two-pill chemical-abortion regimen when it did so nearly 25 years ago.
The plaintiffs argue that the FDA failed to study the regimen’s safety adequately and obstructed doctors from challenging the approval for almost two decades. Instead of increasing scrutiny, the FDA removed existing safeguards and made the drug easier to obtain, according to the pro-life organization.
Mifepristone now accounts for over half of all U.S. abortions.
Kacsmaryk held a preliminary hearing on March 15, where the plaintiffs requested a temporary withdrawal or suspension of mifepristone’s approval while the legal case proceeds. Despite efforts to maintain a low profile, news of the hearing spread, and court staff faced security issues, including death threats, concerning the case.
During the hearing, Kacsmaryk appeared sympathetic to the abortion-pill challengers, questioning the government’s accelerated approval process for mifepristone and the safety of recent FDA decisions. However, he challenged the plaintiffs to provide precedent for a court ordering the FDA to revoke long-standing drug approval. The plaintiffs claimed they have been fighting mifepristone’s approval through the FDA’s internal processes for two decades.
As the hearing occurred, a small group of protesters dressed as judges, clowns, and kangaroos demonstrated outside, with signs reading “Not Your Uterus, Not Your Decision” and “Defend Medication Abortion.” Abortion-rights supporters accused Kacsmaryk of running a “kangaroo court” and being a “lifelong right-wing activist.” Critics also allege that the lawsuit was filed in Amarillo, Texas, to ensure Kacsmaryk’s involvement.
The FDA approved the regimen under Subpart H, allowing expedited approval of potentially dangerous drugs for serious or life-threatening illnesses or providing a meaningful therapeutic advantage over existing treatments. The plaintiffs argue that pregnancy is not an illness, and the pills are more dangerous than surgical abortion without offering a significant therapeutic benefit.
While the federal government has recently made it easier to obtain abortion pills, proponents of legalized abortion pills reject the notion that they are dangerous. Government lawyers contend that mifepristone has been used safely in the U.S. for over two decades, with serious adverse events being rare through 70 days of gestational age.
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